A Phase II Trial of Venetoclax Plus Acalabrutinib for Patients Relapsed After First-Line Venetoclax and Anti-CD20 Antibody Treatment for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

What this Trial Is About

Researchers are investigating a new treatment approach for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have relapsed after initial therapy with venetoclax combined with anti-CD20 monoclonal antibodies. The study aims to evaluate the effectiveness of retreatment using a combination of venetoclax and acalabrutinib, a selective BTK inhibitor, without repeating the anti-CD20 antibody. This approach addresses the need for evidence on retreatment efficacy after fixed-duration venetoclax regimens, which are becoming standard first-line treatments. In this phase II trial, participants will first receive two cycles of acalabrutinib at a dose of 100 mg twice daily. Then, venetoclax treatment will be gradually increased (ramped up) to a daily dose of 400 mg, combined with continued acalabrutinib for 24 cycles. Treatment will continue until a total of 26 cycles are completed or until disease progression occurs, whichever happens first. This combination is expected to achieve undetectable minimal residual disease (uMRD), potentially allowing therapy discontinuation. During the study, participants will undergo assessments to measure uMRD in bone marrow by flow cytometry after 26 cycles. Researchers will monitor treatment response, safety, and tolerability throughout the trial. Participants are expected to follow the visit schedule and protocol requirements, including informed consent. The study provides detailed monitoring over approximately 26 months, with the possibility of discontinuing therapy based on disease status or progression.

REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)